According to the World Health Organization, antimicrobial resistance (AMR) has been declared a top 10 global public health threat and is expected to get worse unless action is taken. It threatens to undermine the basis of modern medicine by rendering the antibiotics used to treat and prevent infections ineffective.Leading the way
BSI has developed this certification program, in partnership with the AMR Industry Alliance, with consultation from financial investors, NGOs, government, regulators, and healthcare system procurers who purchase antibiotics from pharmaceutical manufacturers.
With a stringent qualification of the right assessor expertise and robust assessment protocols, BSI carries out assessments on the antibiotic products through on-going 3-year certification cycle to validate the adherence to the Antibiotic Manufacturing standard and continuous improvement. By achieving the BSI Kitemark certification, manufacturers can demonstrate that their antibiotics have been manufactured with effective controls in place by identifying risk, minimizing antibiotic waste entering waste streams, and validating their data to confirm their Predicted Effective Concentration (PEC) is below a threshold level as determined in the AMRIA Manufacturing standard.
Certification can be awarded to both antibiotic APIs (active pharmaceutical ingredients) and antibiotic finished drug products.
